Efficacy and Safety of IRE for RMs

NCT02298608 | Unknown Phase 1 DMC

• 1 other identifier: NL 44785.018.13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system. The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of this new technology. Primary Objectives:

• To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
• To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events. Secondary Objectives:
• To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
• To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. Population: 10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy. Intervention: Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.

Conditions

Kidney Cancer

Keywords

Renal mass; Kidney cancer; Irreversibel Electroporation; Ablation; Safety; Efficacy; IRE

Outcome Measures

Primary Outcomes (2)

• The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability.

  1 month

• Number of device and procedural adverse events using CTCAE v4.0.

  1 month

Secondary Outcomes (2)

• The efficacy of MRI in the imaging of ablation success

  1 month

• The efficacy of CEUS in the imaging of ablation success

  1 month

Study Arms (1)

Irreversible Electroporation

EXPERIMENTAL

Percutaneous, CT guided, Irreversible Electroporation of renal mass

Device: Nano Knife

Interventions

Nano Knife DEVICE

Percutaneous, CT guided, ablation of renal mass

Also known as: Irreversible Electroporation

Irreversible Electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Solid, enhancing mass on cross sectional imaging
• Scheduled for a radical nephrectomy, open or laparoscopic.
• Signed informed consent

You may not qualify if:

• Irreversible bleeding disorders
• Inability/unwillingness to interrupt anticoagulation therapy
• Previous cryoablation, RFA or partial nephrectomy in affected kidney
• Anaesthesia Surgical Assignment (ASA), category ≤ IV
• ICD / pacemaker
• Severe cardiovascular disease in medical history

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Dept. Urology, Academic Medical Center, Amsterdam

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• Wagstaff PG, de Bruin DM, Zondervan PJ, Savci Heijink CD, Engelbrecht MR, van Delden OM, van Leeuwen TG, Wijkstra H, de la Rosette JJ, Laguna Pes MP. The efficacy and safety of irreversible electroporation for the ablation of renal masses: a prospective, human, in-vivo study protocol. BMC Cancer. 2015 Mar 22;15:165. doi: 10.1186/s12885-015-1189-x.

  PMID: 25886058 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Prof. M. Pilar Laguna Pes, M.D. Ph.D.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Prof. Jean J de la Rosette, M.D. Ph.D.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

Central Study Contacts

Prof. M. Pilar Laguna Pes, M.D. Ph.D.

CONTACT

+31(0)20-5668637; m.p.lagunapes@amc.nl

Peter GK Wagstaff, M.D.

CONTACT

+31(0)205666493; p.g.wagstaff@amc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

NL (1)